| Primary Device ID | 08809986604019 |
| NIH Device Record Key | b45bc3c9-c65b-43dc-98a5-8aaebf98ba2b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMII GPS Digital KIT |
| Version Model Number | AGDK |
| Company DUNS | 631169224 |
| Company Name | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809986604019 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
[08809986604019]
Nitrogen Dioxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-02 |
| Device Publish Date | 2024-01-25 |
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| 08800039307802 - Guide Drill | 2025-09-01 |
| 08800039307819 - Magic Depth Drill | 2025-09-01 |
| 08800039307826 - Magic Depth Drill | 2025-09-01 |
| 08800039307864 - Guide Drill | 2025-09-01 |